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Clinical Trials in Canada / NCT06855953
Starting soon Not applicable

Vitamin K and Cognition in Coronary Heart Disease (NutriCog)

NCT06855953 · tracked via the Priya Life Science Canada tracker
Sponsor
Montreal Heart Institute
Phase
Not applicable
Started
2025-03-17
Last updated
2025-03-04

Condition(s) studied

Coronary Heart Disease

Investigational drug(s) / intervention(s)

Vitamin KPlacebo

Vitamin K: Participants receive 0.5 mg/day phylloquinone orally for 12 weeks

Placebo: Participants receive daily placebo for 12 weeks

Study summary

The purpose of this pilot study is to obtain a preliminary assessment of the effect of VK supplementation on cognitive performance and vascular function in adults with stable Coronary Heart Disease (CHD)

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Men and women * Age 60 years and older * Medically documented stable Coronary Heart Disease (CHD) * Daily dietary intakes of phylloquinone \<150 mcg * Non-consumption of vitamin K supplements (i.e. K1 or K2, singly or in combination with other nutrients), or other cognitive aids * Good French or English understanding * Physical exercise not exceeding 2.5 hours/week of moderate to vigorous aerobic activity * Capacity and willingness to sign informed consent Exclusion Criteria: * Recent acute coronary syndrome (\<3 months) or recent coronary revascularization (bypass surgery or percutaneous coronary intervention, \<3 months) * Known left ventricular dysfunction (LVEF \< 40%) or chronic heart failure * Recent modification of medication (\<2 weeks) * Warfarin (Coumadin) use * Cognitive impairment (based on telephone version of the Mini-Mental State Examination test, score \<19/23) * Diagnosis of depression or uncontrolled anxiety * Malabsorption disorder (advanced liver disease, Crohn's disease) * Patient with auditory or vision impairments not properly corrected by glasses or hearing aids * Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor

Primary outcome measure(s)

  • Change in general cognitive functioning — Baseline and post-intervention at 12 weeks
    Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning)
  • Change in processing speed — Baseline and post-intervention at 12 weeks
    Processing speed is assessed using the Coding subtest from the Wechsler Adult Intelligence Scale (WAIS)IV. The participant is asked to reproduce, as rapidly as possible, a series of symbols associated with digits in a 2-min time period
  • Change in executive functions — Baseline and post-intervention at 12 weeks
    Executive function is assessed using 1. Delis-Kaplan Executive Function System (D-KEFS) subtests \[Trail Making Test; Phonological and Semantic Fluency test \[Letters P, T, L (60s maximum); Categories: animals, men's names (60s maximum)\] 2. WAISIV subtests ("Switching" between naming fruit and furniture (60s maximum)\] 3. Neuropeak platform developed by Dr Bherer's laboratory: dual-task (divided attention) and n-back (working memory and updating). These tasks are tablet/computer-based As these tests use different scales, z-scores will be calculated for the different tests and a composite z-score will be generated for the domain
  • Change in episodic memory — Baseline and post-intervention at 12 weeks
    Episodic memory is assessed using: 1. Rey auditory verbal learning test (RAVLT). Score 0-75, with a higher score indicating a better memory 2. Digit span, a test that requires participants to repeat series of digits of increasing length As these tests use different scales, z-scores will be calculated for the different tests and a composite z-score will be generated for the domain

Trial sites (1)

FacilityCityRegionStatus
Montreal Heart Institute Montreal Quebec

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Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial Recruiting
Home-based Heat Therapy for Type 2 Diabetes Recruiting
Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone Recruiting

Other trials for the same condition

Exercise Training in Women With Heart Disease 2 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855953 on ClinicalTrials.gov ↗ ← All trials in Canada